Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00708435
First received: July 1, 2008
Last updated: January 1, 2014
Last verified: September 2013
Results First Received: June 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Blood Coagulation Disorders
Acute Major Bleeding
Interventions: Biological: Beriplex® P/N (Kcentra)
Biological: Fresh frozen plasma

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Beriplex® P/N Beriplex® P/N : Single intravenous infusion as required to treat acute major bleeding; dosage 25, 35 or 50 units/kg depending on baseline INR, amount of coagulation factor IX and body weight.
Fresh Frozen Plasma Fresh frozen plasma : Single intravenous infusion as required to treat acute major bleeding; dosage 10, 12, or 15 mL/kg depending on baseline INR and body weight.

Participant Flow:   Overall Study
    Beriplex® P/N     Fresh Frozen Plasma  
STARTED     107     109  
COMPLETED     82 [1]   92 [1]
NOT COMPLETED     25     17  
Death / Serious Adverse Event                 10                 5  
Lost to Follow-up                 9                 4  
Withdrawal by Subject                 3                 7  
Adverse Event                 1                 0  
Protocol Violation                 0                 1  
Intervention by primary care physician                 1                 0  
Refused hospitalization                 1                 0  
[1] These data are 'on-study' results collected up to the subject's Day 45 visit.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Intention-to-treat population comprised all subjects who were (1) eligible for the study and had (2) signed informed consent and were randomized to 1 of the 2 treatment groups regardless of whether the subjects received study product. In the ITT population, subjects were analyzed “as randomized”.

Reporting Groups
  Description
Beriplex® P/N Beriplex® P/N : Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight
Fresh Frozen Plasma Fresh frozen plasma : Intravenous Infusion, dosage depending on baseline INR and body weight
Total Total of all reporting groups

Baseline Measures
    Beriplex® P/N     Fresh Frozen Plasma     Total  
Number of Participants  
[units: participants]
  107     109     216  
Age, Customized  
[units: Participants]
     
< 65 years     36     32     68  
≥ 65 to < 75 years     28     29     57  
≥ 75 years     43     48     91  
Gender  
[units: participants]
     
Female     52     55     107  
Male     55     54     109  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving Hemostatic Efficacy of Stopping an Ongoing Major Bleed   [ Time Frame: At 1 and 4 hours after the end of infusion ]

2.  Primary:   Percentage of Participants Who Had a Rapid Decrease of the International Normalized Ratio (INR)   [ Time Frame: 30 minutes after end of infusion ]

3.  Secondary:   Percentage of Participants Who Had Hemostatic Efficacy for Visible or Non-visible Musculoskeletal Bleeding   [ Time Frame: At 3 and 6 hours after the start of infusion ]

4.  Secondary:   Incremental in Vivo Recovery (IVR) (Response) of Factors II, VII, IX, and X, Protein C, and Protein S for Beriplex   [ Time Frame: Before infusion and up to 3 h after the start of infusion ]

5.  Secondary:   Plasma Levels of Factors II, VII, IX, and X, Protein C, and Protein S   [ Time Frame: From preinfusion until 24 h after the start of infusion ]

6.  Secondary:   Percentage of Participants With INR Correction at Various Times After the Start of Infusion   [ Time Frame: From the start of infusion until INR correction; calculated at 0.5, 1, 3, 6, 12, and 24 h after the start of infusion. ]

7.  Secondary:   Percentage of Participants With INR Correction at Various Times After Randomization   [ Time Frame: From randomization until INR correction; calculated at 2.5, 3, 5, 8, 14, and 26 h after randomization. ]

8.  Secondary:   Transfusion of Red Blood Cells   [ Time Frame: From the start of infusion until 24 h after the start of infusion ]

9.  Secondary:   Use of Other Blood Products and Hemostatic Agents   [ Time Frame: From the start of infusion until 24 h after the start of infusion ]

10.  Secondary:   45-Day All-cause Mortality   [ Time Frame: Until Day 45 ]

11.  Secondary:   Overall Treatment-emergent Adverse Events (TEAEs)   [ Time Frame: From the start of infusion up to the allowed time window of the Day 10 visit for non-serious AEs and from the start of infusion up to the allowed time window of the Day 45 visit for SAEs. ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Behring
phone: Use email contact
e-mail: clinicaltrials@cslbehring.com


Publications of Results:

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00708435     History of Changes
Other Study ID Numbers: BE1116_3002, 1462, 2007-007861-19
Study First Received: July 1, 2008
Results First Received: June 7, 2013
Last Updated: January 1, 2014
Health Authority: United States: Food and Drug Administration
Bulgaria: Bulgarian Drug Agency
Ukraine: State Pharmacological Center - Ministry of Health
Armenia: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Belarus: Ministry of Health
Romania: National Medicines Agency